NCT01341106

Induction of Fibrosis Regression on Patients With Chronic Hepatitis B Infection

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will examine whether 12 month treatment with entecavir(Baraclude®) has an effect on changes of liver stiffness measurement (LSM) and of hyaluronan measurement in patients with chronic hepatitis B infection.

Detailed description

Patients with chronic hepatitis B infection and relevant liver fibrosis will be treated with entecavir during 5 years or until anti-HBs seroconversion or 6-12 months after anti-HBe seroconversion and HBeAg loss. There are 9 visits during treatment for each patient. At all visits, each patient will consent to give 20 ml blood sample for study examination and 40 ml blood sample for research purposes.

Conditions

• Hepatitis B, Chronic
• Liver Fibrosis

Interventions

Type	Name	Description
DRUG	Treatment with entecavir(Baraclude®)	Patient will be daily treated with 1 tablet of entecavir per oral

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-01-01
• Completion: 2015-04-01
• First posted: 2011-04-25
• Last updated: 2015-09-23

Locations

1 site across 1 country: Germany